AABB Standards and Accreditation Doug Padley, MT (ASCP) Mayo Clinic Rochester MN USA
Objectives Review AABB standard setting process Describe accreditation program
What is AABB? International association Dedicated to transfusion medicine and cell therapy Standard setting / accreditation for 50 yrs. 8,000 individual members 1,800 institutional members 50 states 80 countries
Standards Overview Based on ISO and Quality Systems Include Quality System and Technical standards Standards not prescriptive Flexible Allow for innovation and technology Facilities must meet all requirements 18 month cycle for new editions To keep up with rapidly changing science and technology Tools Assessment tools (guidance/inspection preparation) Commendable practice on web (examples of SOPs, forms, etc)
AABB Standards Chapter Titles (5 th Edition) Organization, Resources Equipment Agreements Process Control Documents and Records Deviations and Nonconforming Products or Services Internal and External Assessments Process Improvement
Standards Review and Updates Based on new evidence Changes in regulations Changes in standard of care Input from membership, SPU members, and accredited facilities CT SPU has a defined algorithm for changing standards AABB has mechanism for public/membership notification
The Evolution of AABB Cellular Therapy Standards 1991-96 1996 2000 2001 2002 2004-11 Part of BB TS Standards 1 st Edition HPC Standards 2 nd Edition HPC Standards 1 st Edition Cord Blood Standards 3 rd Edition HPC Standards 1 st -5 th Edition Cellular Therapy Stds Combined with 1 st ed. cord blood (2001) and 3 rd edition HPC
Format of AABB CT Standards Cascading pattern: General quality standards Technical standards that apply to all cellular therapy products Technical standards that are specific to the type of product or donor Reference standards (most detailed requirements in book) C or F = Corresponding record required Refer to retention time for records (6.2.10) From Creation or Final Disposition
5.0: Process Control 5.7 Verification of Donor Eligibility F 5.7.2 Donor identity: Requires 2 identifiers at procurement 5.7.2.1 Additional requirements for cord blood: requires identification of the birth mother before procurement. Reference standard 5.7.1.A Contains more detail about donor eligibility requirements
The Standards Program Unit Content experts Technical Scientific Regulatory An ethicist (may also serve as public rep) Representative from AABB accreditation program unit Representatives from other organizations (AATB, ACOG, ASBMT, ASFA, ASH, FACT, FDA, ISCT, NMDP) Physicians Lab Directors Clinicians
AABB Accreditation Program Based on Standards Program has policies regarding: Conflict of interest Confidentiality Assessor technical expertise Organization of accrediting body Impartiality Internal and external validation of assessments
The Process Assessment team and duration of assessment based on services and volume Team includes AABB staff assessor plus others Either facility or assessor may decline Not same assessor for sequential cycles Unannounced (within an approved date range) Written policies and procedures Dispute process (Accreditation Review Cmte) Assessor CE requirements (content and quantity) Variance process Facility can request variance from standards, reviewed by CT SPU
Accreditation Spans Entire Process Collection sites Testing sites Processing sites Storage sites Infusion sites Off-site collection facilities (incl UCB) Physically assess minimum of one site or 10% (greater of the two since 1998)
International Accreditation Allows accreditation with variances from certain standards Infectious disease testing kits in some countries may not be US FDA approved Country specific Government/Health Ministry Policies that are not compliant with AABB standards International Accreditation is noted on AABB web site.
Efforts Towards Harmonization of Cellular Therapy Standards AHCTA, A formal worldwide group with broad representation The Circular of Information- new revision in early development The ISBT 128 working group
Questions Contact us at standards@aabb.org